CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated 
Mylan Pharmaceuticals Inc.

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Drug Facts

Active ingredient

Cetirizine Hydrochloride 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children
6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than
2 tablets in 24 hours.
adults 65 years
and over
1 tablet once a day; do not take more than
1 tablet in 24 hours
children under
6 years of age
ask a doctor
consumers with liver
or kidney disease
ask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions?

call 1-877-446-3679

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

PRINCIPAL DISPLAY PANEL - 5 mg Allergy

NDC 0378-3635-93

Cetirizine Hydrochloride
Tablets 5 mg
antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

30 TABLETS

RM-AR3635H

Tamper Evident: do not use if foil seal under
cap is missing, open or broken.

Cetirizine Hydrochloride Tablets 5 mg Allergy Cartons
Cetirizine Hydrochloride Tablets 5 mg Allergy Cartons Front
Cetirizine Hydrochloride Tablets 5 mg Allergy Cartons Back

PRINCIPAL DISPLAY PANEL - 10 mg Allergy

NDC 0378-3635-93

Cetirizine Hydrochloride
Tablets 10 mg
antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

30 TABLETS

RM-AR3637H

Tamper Evident: do not use if foil seal under
cap is missing, open or broken.

Cetirizine Hydrochloride Tablets 10 mg Allergy Cartons
Cetirizine Hydrochloride Tablets 10 mg Allergy Cartons Front
Cetirizine Hydrochloride Tablets 10 mg Allergy Cartons Back

Active ingredient

Cetirizine Hydrochloride 10 mg

Purpose

Antihistamine

Uses

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • swelling of tongue
  • trouble speaking
  • wheezing or problems breathing
  • dizziness or loss of consciousness
  • swelling in or around mouth
  • drooling

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector.

If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves

      because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

  • liver or kidney disease. Your doctor should determine if you need a different dose.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

If pregnant or breast-feeding

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children
6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than
2 tablets in 24 hours.
adults 65 years
and over
1 tablet once a day; do not take more than
1 tablet in 24 hours
children under
6 years of age
ask a doctor
consumers with liver
or kidney disease
ask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions?

call 1-877-446-3679

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

 PRINCIPAL DISPLAY PANEL - 5 mg Hives Relief

NDC 0378-3635-93

Cetirizine Hydrochloride
Tablets 5 mg
antihistamine

24
HOUR

Relief of
ITCHING
Due to Hives

Tamper Evident: do not use if foil seal under cap
is missing, open or broken

30 TABLETS

RM-H3635H

Cetirizine Hydrochloride Tablets 5 mg Carton
Cetirizine Hydrochloride Tablets 5 mg Carton Front
Cetirizine Hydrochloride Tablets 5 mg Carton Back

 PRINCIPAL DISPLAY PANEL - 10 mg Hives Relief

NDC 0378-3637-93

Cetirizine Hydrochloride
Tablets 10 mg
antihistamine

24
HOUR

Relief of
ITCHING
Due to Hives

Tamper Evident: do not use if foil seal under cap
is missing, open or broken

30 TABLETS

RM-H3637H

Cetirizine Hydrochloride Tablets 10 mg Carton
Cetirizine Hydrochloride Tablets 10 mg Carton Front
Cetirizine Hydrochloride Tablets 10 mg Carton Back
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0378-3635
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
HYPROMELLOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code M;C35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-3635-01100 in 1 BOTTLE, PLASTIC
2NDC:0378-3635-05500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667712/14/2009
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0378-3637
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
HYPROMELLOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code M;C37
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-3637-01100 in 1 BOTTLE, PLASTIC
2NDC:0378-3637-05500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667712/14/2009
Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 11/2009
 
Mylan Pharmaceuticals Inc.